FDA product code · Clinical chemistry

Radioimmunoassay, Total Estrogens, Nonpregnancy

Name: FDA decisions, review times, recalls and adverse event reports for product code JMD
Creator: 510(k) Report

JMDClass I21 CFR 862.1275510(k) exempt2 decisions since 19780 recalls

FDA lists JMD as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 862.9 applies, such as a new intended use or a different fundamental technology. 2 FDA decisions since 1978. No recall names this code.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, clinical chemistry panel

Twenty years of JMD at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · JMD

FDA has decided no JMD device since 2007.

Median 510(k) review, days · JMD

Too few JMD 510(k)s in any year since 2007 to give a median.

Recalls per year · JMD

No recall names JMD since 2007.

Adverse event reports per year · JMD

No MAUDE report names JMD since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

FIG. 1 — JMD by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in JMD? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Radioimmunoassay, Total Estrogens, Nonpregnancy

What has FDA decided in JMD lately?